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Senior Director, Clinical Research
Location
United States
Posted
123 days ago
Salary
$290K - $300K / year
Seniority
Lead
No structured requirement data.
Job Description
Senior Director, Clinical Research
Nuvation Bio
Role Description The Senior Director, Clinical Research serves as a key scientific and functional program lead as part of the CRS team. The CRS will be empowered to work collaboratively and cross-functionally to support and implement strategic objectives including clinical development plan. You will be responsible for: - Develop and support the clinical scientific strategies of the Clinical Development Plan (CDP) - Contribute to the design, start-up, execution, analysis and communication of the clinical studies for a product candidate - Review and author clinical documents as needed - Deep understanding and familiarity with assigned study and protocol requirements - Responsible for scientific oversight, data integrity and quality of the clinical trials(s) with attention to details to all aspects of assigned clinical studies - Drive and support all study related activities including: - Maintenance of clinical documents - Protocol writing, amendments, informed consent - Provide study related data to support regulatory documents (IB, regulatory documents, etc) - Site and CRA training - Site selection and activation in collaboration with clinical operation - Collaborate with clinical operation to define study activities, deliverables, instructions relating to assigned studies (e.g. IVRS, central lab, site monitoring plan, lab manual, etc) - Eligibility review - Data review, analysis and interpretation of clinical trial data - Demonstrate advanced understanding of clinical protocols - In collaboration with Clinical Operations, responsible for timely delivery of high-quality clinical study data analysis - Form and enhance working relationships with external clinical research partners/vendors to support clinical development of a drug product candidate - Support regulatory activities, medical affairs, and payer engagements; represent Nuvation Bio in external scientific and medical forums Qualifications - Advanced Degree in life sciences (medicine, pharmacy, biology, etc) - 10+ years of working experience in clinical research/development in Phase 3/pivotal space in Oncology or equivalent with demonstrated proficiency in clinical research and development - Experience in pivotal study conduct and regulatory interactions with the FDA (additional global regulatory authorities is a plus) - Extensive data listing review experience for pivotal studies - Demonstrated ability to lead the development of project strategy and to be accountable for project plans, timelines, progress, and outcomes - Expert knowledge in ICH/GCP and all aspects of clinical research and development including study design, statistics, and clinical operation - Experienced in protocol writing, data review and cleaning, ability to analyze, interpret and communicate data with clarity - Deep knowledge in disease, competitive landscape, pipeline compounds, and regulatory requirements - Strong knowledge of other key functional areas (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated - Proven leadership and collaboration skills in managing teams both directly and indirectly - Ability to work and lead in a matrix environment - Ability to effectively communicate and present data in front of external audience and at multiple levels within the organization - Ability to travel nationally and internationally as needed - An equivalent combination of education and experience may be considered Requirements - Problem-Solver: As an action-oriented self-starter, eager to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges - Personable: Establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives - Credible: Thorough understanding of clinical methodologies and providing sound analytical support, quickly establishing credibility as a reliable resource - Emotional intelligence, curiosity, and a knack to figure out a way to build something better - Communication: Effectively listens, conveys, and receives ideas. A strong presenter and effective communicator with the ability to influence stakeholders - Accountability: Acts with a clear sense of ownership. Holds yourself and others accountable to execute all tasks at hand with high quality and integrity - Adaptability: Can manage in an environment of ambiguity. Embraces change and reassesses priorities as needed Benefits - Competitive Base Salary, Bonus, and Equity Plans - Unlimited Vacation and 10 Sick Days Annually - Excellent Medical, Dental, and Vision Coverage - 401K with Company Matching - And much more!
Job Requirements
- Advanced Degree in life sciences (medicine, pharmacy, biology, etc)
- 10+ years of working experience in clinical research/development in Phase 3/pivotal space in Oncology or equivalent with demonstrated proficiency in clinical research and development
- Experience in pivotal study conduct and regulatory interactions with the FDA (additional global regulatory authorities is a plus)
- Extensive data listing review experience for pivotal studies
- Demonstrated ability to lead the development of project strategy and to be accountable for project plans, timelines, progress, and outcomes
- Expert knowledge in ICH/GCP and all aspects of clinical research and development including study design, statistics, and clinical operation
- Experienced in protocol writing, data review and cleaning, ability to analyze, interpret and communicate data with clarity
- Deep knowledge in disease, competitive landscape, pipeline compounds, and regulatory requirements
- Strong knowledge of other key functional areas (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
- Proven leadership and collaboration skills in managing teams both directly and indirectly
- Ability to work and lead in a matrix environment
- Ability to effectively communicate and present data in front of external audience and at multiple levels within the organization
- Ability to travel nationally and internationally as needed
- An equivalent combination of education and experience may be considered
- Problem-Solver: As an action-oriented self-starter, eager to apply expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
- Personable: Establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
- Credible: Thorough understanding of clinical methodologies and providing sound analytical support, quickly establishing credibility as a reliable resource
- Emotional intelligence, curiosity, and a knack to figure out a way to build something better
- Communication: Effectively listens, conveys, and receives ideas. A strong presenter and effective communicator with the ability to influence stakeholders
- Accountability: Acts with a clear sense of ownership. Holds yourself and others accountable to execute all tasks at hand with high quality and integrity
- Adaptability: Can manage in an environment of ambiguity. Embraces change and reassesses priorities as needed
Benefits
- Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- And much more!
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